Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Status: Active_not_recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Observational
SUMMARY

In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS. This is known as an observational study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are: * Those who took DRF during their pregnancy * Those who took disease-modifying therapies (DMTs) for RMS during their pregnancy, but not DRF. DMTs are drugs that slow how the disease develops over time, not just relieve symptoms. * Those who did not take any drugs for RMS during their pregnancy The main question researchers want to learn about in this study is: • How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth. In this study, researchers will measure how often the following outcomes happen and compare them between groups: * Loss of pregnancy before 20 weeks * Loss of pregnancy at or after 20 weeks (stillbirth) * Babies born early (before 37 weeks) * Babies who are smaller than expected for the stage of pregnancy * Live births This study will be done as follows: * The study includes data in adult women with multiple sclerosis on pregnancies happening between October 29th, 2019 and July 31st, 2030. Information will start being collected when the participant decides to join the study. * Medical records and clinical notes will be reviewed at the end of the study. * The study will include information from pregnancy through delivery, and for babies up to 1 year after birth. * The study is planned to end by 30th April 2031.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• Last menstrual period (LMP) between 29 October 2019 and 31 July 2030.

• Continuous medical Optum Research Database (ORD) and pharmacy (ORD and Market Clarity) coverage for a minimum of 6 months prior to and including the estimated LMP.

• Presence of MS.

Locations
United States
Minnesota
OptumInsight
Eden Prairie
Time Frame
Start Date: 2021-09-24
Completion Date: 2031-01-17
Participants
Target number of participants: 1178
Treatments
Diroximel Fumarate (DRF)
Pregnant women with MS who were exposed to DRF.
Non-DRF
Pregnant women with MS who were exposed to disease-modifying therapies (DMTs) other than DRF.
Non-DMT
Pregnant women with MS who were not exposed to DMTs.
Related Therapeutic Areas
Sponsors
Leads: Biogen

This content was sourced from clinicaltrials.gov